High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2024-10-01

Brief Summary

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This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.

Detailed Description

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Conditions

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Cerebral Atherosclerosis

Keywords

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atherosclerosis plaque burden Evolocumab High-Resolution assessment OCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolocumab treatment group

Evolocumab treatment, 1ml：140mg, every 2 weeks, for 26 weeks

Group Type EXPERIMENTAL

Evolocumab 140 MG/ML

Intervention Type DRUG

Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times

Intensive statin treatment group

Atorvastatin 40mg/day or rosuvastatin 20mg/day, for 26 weeks

Group Type ACTIVE_COMPARATOR

Intensive statin treatment

Intervention Type DRUG

Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks

Interventions

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Evolocumab 140 MG/ML

Evolocumab 140mg, subcutaneous injection, every 2 weeks, for 26 week, total 13 times

Intervention Type DRUG

Intensive statin treatment

Intensive statin could choose either Atorvastatin 40mg/day or Rosuvastatin 20mg/day, for 26 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years old, regardless of sex;
2. Cerebrovascular angiography examination was performed, and the imaging characteristics were consistent with: 1) The stenosis degree of internal carotid artery (starting from C1 segment) or vertebral artery (starting from vertebral artery to V4 segment) was 20%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;
3. Participants who understand and sign the informed consent form voluntarily.

Exclusion Criteria

1. Intolerant to both atorvastatin and rosuvastatin;
2. History of major surgery or endovascular treatment within 3 months prior to the screening period;
3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
4. Abnormal liver function (ALT \> 3 times the upper limit of normal);
5. Renal dysfunction (glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 at screening);
6. Thrombocytopenia (PLT\<100G/L);
7. The expected survival time is not more than 6 months;
8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;
9. Patients have been included in other studies that conflict with this study;
10. Known sensitivity to any of the products or components to be administered during dosing;
11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;
12. Other conditions that the investigator considered inappropriate for enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hu Bo

head of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR